College Pharmacy, Inc. — FDA 483 Findings

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

Test procedures relative to appropriate laboratory testing for sterility are not written.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

Clothing of personnel engaged in the processing and packing of drug products is not appropriate for the duties they perform.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.